Kornimate/medical-research-clean huggingface dataset:
multicenter orthopaedics outcomes network for acl reconstructions

Conditions: Rupture of Anterior Cruciate Ligament

Summary: the purpose of this study is to determine the effect of modifiable risk factors on knee function, osteoarthritis, and re-rupture of the anterior cruciate ligament (acl) following acl reconstruction.

disruption of the anterior cruciate ligament (acl) is among the most frequent musculoskeletal injuries affecting physically active men and women. an estimated 200,000 acl reconstructions (aclr) are performed annually, and the incidence of this injury is roughly 1 in 3000 per year. acl injury has both immediate and long-term implications for an injured person's quality of life, their risk for osteoarthritis (oa), and long-term disability. currently, aclr is recommended as the standard of care following an acl tear based on evidence for improved instrumented laxity, the desire to return to sports play, and evidence for a reduction in future knee injuries. in this research we propose to identify risk factors measurable at the time of injury/surgery in order to estimate the magnitude of the effect of these factors on important quality of life and clinical outcomes (e.g.,oa and incidence of additional surgery) 2 to 10 years after a patient's acl reconstruction. aim 1. to identify risk factors for reduced quality of life 2-20 yrs post-aclr, from information available at the time of surgery; including the characteristics of the patients (age, gender, body mass index, activity level, clinical knee alignment) and their injuries (concurrent meniscus, articular cartilage, and collateral ligament injuries), and treatment decisions made during the initial surgery (e.g., graft choice, meniscus and articular cartilage treatments). aim 2. to identify risk factors for symptoms and signs of osteoarthritis 2-20 years post-aclr, from information available at the time of surgery; including the characteristics of the patients (as above) and their injuries (as above), and treatment decisions made during aclr (as above). aim 3. to identify risk factors for recurrent ligament disruption and additional arthroscopic knee surgeries of the aclr knee, from among the characteristics of the patients (as above), their initial injuries (as above), and treatment decisions made during aclr (as above). the overarching goal of this study is to establish evidence-based medicine practices of counseling patients on prognosis, guiding surgeons on treatment of meniscus and articular cartilage injuries, and post-surgical care, as well as the appropriate evidence for future interventional trials in the targeted subset of aclrs with poorer outcomes.

Eligibility criteria:
inclusion criteria: - all acl-deficient candidates scheduled for a unilateral acl reconstruction at one of the participating moon sites. exclusion criteria: * persons undergoing a simultaneous bilateral acl reconstruction * patients less than 10 years old and older than 80 years old * patients unwilling or unable to complete their follow-up questionnaire

Keywords: anterior cruciate ligament/injuries anterior cruciate ligament/surgery knee injuries/surgery outcomes research prospective studies
study of multifrequential impedancemetry in pulsatile tinnitus

Conditions: Pulsatile Tinnitus

Summary: this study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus.

the multifrequency admittancemetry is known to reflect several parameters of the middle ear and the external ear. more recently it appears to also reflect some parameters of the inner ear, such as the perilymph pressure. furthermore, investigators do not know exactly the physiopathology of pulsatile tinnitus that are from veinous etiology. modifications of the perilymphatic pressure could be implicated. investigators intended to search for a relationship between these both theories. investigators will include every patient that consult to ear, nose and throat unit of bordeaux university hospital with a pulsatile tinnitus trouble, and perform multifrequential admittancemetry. if a radio-surgical intervention is scheduled for a venous stenosis, the test will also be performed test after the surgery. if there is no surgical intervention, no follow-up will be required.

Eligibility criteria:
inclusion criteria: * adult patient * unilateral or bilateral pulsatile tinnitus * pulsatile tinnitus \> 1 month old * affiliated or beneficiary of by social security system exclusion criteria: * otological surgery, excluding trans-tympanic aerators in childhood with closed eardrum * middle ear abnormality (any type of partial or total filling of the middle ear) noted on otoscopy or subsequent mri scan * abnormal eardrums excluding tympanosclerosis * non-pulsatile tinnitus * conductive hearing loss with abolition of stapedial reflexes * minor patient * major protected * abnormal tympanometry at 226 hz * presence of rotatory vertigo * opposition to participation expressed by patient

Keywords: pulsatile tinnitus multifrequency admittancemetry
validity of electronic diary for monitoring varicose veins symptoms

Conditions: Varicose Veins

Summary: the purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.


Eligibility criteria:
inclusion criteria: * sign informed consent and complete study assessments in written english * male or female age 18 to 75 * patients having saphenofemoral junction (sfj) incompetence and scheduled to receive foam sclerotherapy treatment for varicose veins in one leg * screening symptom score of 7 points or more as measured by question 1 on the modified veines-qol/sym questionnaire exclusion criteria: * unable to comply with completing a daily diary for a total of 24 days * participation in any other investigational pharmaceutical product, or device study within the 3 months prior to visit 1 * current venous leg ulcer in either leg
effects of head elevation by a bed on sleep-disordered breathing

Conditions: Sleep-disordered Breathing; Obstructive Sleep Apnea

Summary: sleep is known to be a dynamic state of consciousness that is characterized by rapid fluctuations in autonomic activity as well as changes in body postures. body postures during sleep influence the severity of sleep-disordered breathing because a supine position is associated with an increase in upper airway collapsibility and thus an increase in frequency and duration of snoring and apnea. use of an adjustable bed to elevate patients' head might improve those conditions. the purpose of the present study is to determine whether use of an automatic adjustable bed is associated with reducing sleep-disordered breathing in patients with suspected obstructive sleep apnea (osa) due to upper airway problems.

from the chest and otorhinolaryngology department, patients with symptomatic sleep-disordered breathing will be referred to the sleep center. after an interview these subjects will undergo a full-night polysomnography (psg). patients who are eligible for this study will sleep on an automatic adjustable bed with a second psg performed within the next one month. the automatic device is initiated when the patient suffers from apnea ≥ 10 seconds, which is detected by an ultra-wideband (uwb) sensor placed under the bed. the head will be slightly elevated at an angle of 10 degrees lasting 10 seconds and then be put down softly. parameters of sleep efficiency and architecture, apnea-hypopnea index (ahi), and oxygen saturation will be obtained during each psg. according to the severity, enrolled patients will be classified into 4 groups as normal (ahi \ 30). using an automatic adjustable bed will improve sleep-disordered breathing with a reduction of ahi score is assumed. the minimal sample size is estimated to be 14 subjects per group with the intention of providing 80% power and an overall two-sided 5% type i error. a total of 60 subjects (15 subjects per group) will be enrolled to achieve the necessary number of evaluable subjects, anticipating roughly a 10% drop-out rate. informed written consent will be obtained from all subjects. this study was approved by the mackay memorial hospital institutional review board.

Eligibility criteria:
inclusion criteria: * subjects known to have snoring or sleep-disordered breathing exclusion criteria: * refusal to participate * pregnancy * psychiatric disorders * clinical instability in the previous month

Keywords: apnea-hypopnea index obstructive sleep apnea body posture ultra-wideband
determination of voiding patterns of children with vesicoureteral reflux

Conditions: Vesicoureteral Reflux

Summary: determine if the pattern of voiding differs in children with vesicoureteral reflux (vur) compared to those who do not have vur.

we hope to determine the statistical difference between the flow rate and volume of urination in children with vur compared to those without.

Eligibility criteria:
inclusion criteria: * children with or without vesicoureteral reflux (history of vur) * toilet trained and can void on command exclusion criteria: * any voiding disorder, musculoskeletal neurologic disorders, other congenital or acquired genitourinary problems, growth disorders, recent uti

Keywords: voiding patterns flow rate ultrasound
improving uptake of pediatric vaccines through religious conferences and vaccines-in-a-van in aceh, indonesia

Conditions: Vaccination

Summary: the goal of this cluster, randomized controlled trial is to study the impact of mobile vaccine clinics and religious conferences on pediatric vaccination coverage. the main questions will be: does vaccination coverage change in geographic areas with the mobile vaccine clinics vs those areas without mobile vaccine clinics; and does vaccination coverage change in geographic areas with religious conferences on vaccination vs those areas without religious conferences. in repeated surveys, adult participants will respond about their children's vaccination status. participants will not be individually randomized to the interventions. rather, their geographical area will be randomized.

this project seeks to create a paradigm shift in how the public views and utilizes vaccination services. currently, community health centers remain the default setting for vaccination, and clinicians the default administrators. however, the general population may have difficulty accessing these clinics or trusting traditional vaccination providers, particularly if they are members of marginalized communities that have experienced medical discrimination. this project applies a two-pronged approach by addressing issues of trust and ease of access among the general population. this project is innovative by: a) mobilizing religious communities to discuss vaccines (to counter reported lack of information about vaccines among unvaccinated families) and b) training more community health workers in vaccination and in physically delivering vaccines through a "vaccine-in-a-van" concept to facilitate ease in accessing vaccines. by mobilizing these individuals in the community settings where people live, work, worship, and learn, this project will expand vaccine information and services. more specifically, this project plans to work with local health leaders in a low vaccination community in aceh, indonesia to identify social institutions that are part of children and families' daily lives; these could include houses of worship, schools, or community centers. this project will fund a mobile vaccine delivery unit to go to these locations to physically bring vaccines to the people and to link them with existing immunization clinic infrastructure. this project will also work towards changing the culture of child health and vaccination through substantial discussions and conversations with multiple levels of religious leaders at conferences.

Eligibility criteria:
inclusion criteria: * adults 18+, and * proficient in bahasa indonesia, and * plan to live in neighborhood for next year * parent of child \<5, or * planning to have a child within next year
gefitinib in treating patients with stage iiia non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. giving gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. purpose: this phase ii trial is studying how well gefitinib works in treating patients with stage iiia non-small cell lung cancer.

objectives: primary * to assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage iiia (pn2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (egfr) mutations. secondary * to determine the complete resection rate in patients treated with this drug. * to determine the overall survival rate in patients treated with this drug. * to determine the disease-free survival rate in patients treated with this drug. * to determine the pathologic complete response rate in patients treated with this drug. * to determine the toxicity of this drug in these patients. outline: this is a multicenter study. patients receive oral gefitinib once a day on days 1-28. treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients with resectable disease may undergo surgery. patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy. after completion of study therapy, patients are followed for 2 years.

Eligibility criteria:
disease characteristics: * biopsy-proven stage iiia nonsquamous non-small cell lung cancer * pn2 disease proven by mediastinoscopy * meets any of the following criteria: * never smoked * egfr mutations (in exon 18, 19, or 21)\* * fish positive for egfr\* note: \*irrespective of smoking history * presence of at least 1 unidimensionally measurable lesion on thoracic ct scan, according to recist * feasible to undergo pneumonectomy or lobectomy patient characteristics: inclusion criteria: * ecog performance status 0-1 * fev_1 ≥ 2.0 l in preoperative pulmonary function test * hemoglobin ≥ 9.0 g/dl * wbc 4,000-12,000/μl * anc ≥ 1,500/μl * platelet count ≥ 100,000/mm³ * total bilirubin ≤ 1.5 times upper limit of normal (uln) * alkaline phosphatase ≤ 3.0 times uln * ast and alt ≤ 3.0 times uln * creatinine ≤ 1.5 times uln * negative pregnancy test exclusion criteria: * severe complications or infections * pregnant or breast-feeding women * clinically significant heart disease * uncontrolled hepatitis, chronic liver disease, or diabetes mellitus * another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma prior concurrent therapy: * no prior radiotherapy, chemotherapy, hormone therapy, or target therapy * no other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy

Keywords: stage iiia non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer
retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice

Conditions: Rheumatoid Arthritis

Summary: to compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (ra), to determine causes of discontinuation, retention-associated factors, and retention rates of possible second-line tumor necrosis factor α inhibitors (tnfi).

in this retrolective, multicentric study, medical charts of ra patients starting tnfi between march 2005 and april 2009 were reviewed, with follow-up between 2 and 6 years. the retention rate was estimated using the kaplan-meier method. comparison between tnfi was done after adjustment using a cox model. factors associated with better retention were identified by multivariate analysis. medical charts of all patients with ra starting a first tnfα inhibitor therapy between march 1, 2005 (start of commercialization of adalimumab in france) and april 30, 2009 (allowing at least 2 years of follow-up) were systematically reviewed in detail by 2 rheumatologist investigators

Eligibility criteria:
inclusion criteria: * ra defined by the 1987 acr criteria \[18\] * first tnfα inhibitor prescribed in the previously mentioned period * tnfα inhibitor prescribed as first-line biotherapy * undergone at least one evaluation in the center after treatment initiation exclusion criteria: * previously received another biotherapy * tnfα inhibitor was prescribed in an rct * refused to participate

Keywords: retention rates of adalimumab etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice. tnf inhibitors biotherapy retrospective study
evaluating the effect of cromolyn sodium in uremic pruritus

Conditions: End Stage Renal Disease; Pruritus

Summary: pruritus is a major disorder among the skin derangements in advanced renal failure. recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated c fibers may be important in the precipitation and regulation of the sensory stimuli.patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. it is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.


Eligibility criteria:
inclusion criteria: * hemodialysis patients \> 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs * willing and able to give informed concent exclusion criteria: * known dermatologic, liver, metabolic disease, or any other disease or condition other than esrd that causes pruritus * lactase deficiency

Keywords: end stage renal disease cromolyn sodium pruritus tryptase
efficacy pilot study of triflusal in the attenuation of insulin resistance in human obesity

Conditions: Insulin Resistance

Summary: to explore the efficacy of triflusal in the attenuation of insulin resistance in human obesity. triflusal is a salicylate compound approved in several countries as antithrombotic agent (antiplatelet). the hypothesis is to explore if there is a reduction of obesity-induced insulin resistance by triflusal.

double-blind, randomized, cross-over (three periods) with two dose levels of triflusal, placebo-controlled. interventions: treatment periods triflusal 600 mg/d, 15 days triflusal 900 mg/d , 15 days placebo, 15 days washout period: 30 days

Eligibility criteria:
inclusion criteria: * ages 35 to 60 years old

Keywords: insulin resistance and inflamation insulin sensitibity obesity-induced insuline resistence obesity-diabetes link salicylate insulin resistance in obesity health adults
membrane sweeping to prevent post-term pregnancy: the milo study

Conditions: Pregnancy, Prolonged; Induced; Birth; Pregnancy Related

Summary: multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design.

the primary aim of the milo study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. we will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews). methods/design multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design. pregnant women with a live, singleton fetus ≥ 38 weeks gestation, cephalic presentation, longitudinal lie, intact membranes, english speaking and ≥18 years of age will be randomised in a 2:1 ratio to: • membrane sweep versus no membrane sweep women allocated randomly to a sweep will then be randomised further (factorial component) to: * early (from 39 weeks) versus late (from 40 weeks) sweep commencement; and * a single verses weekly sweep the proposed feasibility study consists of four work packages i.e., (1) a multicentre, pilot randomised trial, 2) a health economic analysis and 3) a qualitative study (4) a study within the host trial (a swat).

Eligibility criteria:
inclusion criteria: * pregnant women carrying a live singleton fetus ≥ 38 weeks completed gestation. * (gestational age will be calculated from the first day of the last menstrual period and an * ultrasound examination carried out in the 2nd trimester) * longitudinal lie * cephalic presentation * intact amniotic * ≥ 18 years of age on enrollment exclusion criteria: * not able to communicate in english * contraindications to a vaginal examination * contraindications to a vaginal birth

Keywords: membrane sweep feasibility study randomised trial pilot study swat pregnancy induction of labour post dates prolonged pregnancy
comparative study of three common bile duct closure techniques

Conditions: Common Bile Duct Closure

Summary: this study evaluates the efficacy and safety of three different methods of cbd repair after common bile duct exploration and provides more evidence for selecting the optimal duct closure after choledocholithotomy.

at present, the commonest available options for cbd closure include repair over t-tube drain, primary closure, and repair after antegrade biliary stenting. all three methods present speciﬁc technical performance features, require different postoperative management protocols, and are charged with speciﬁc morbidity related to the procedure and therefore should not be considered the same procedure in the context of cbde. repair over t-tube is the traditional surgical technique. it has many advantages as post-operative distal cbd decompression, trans-tubal cholangiography, and availability of retained cbd stones extraction. however, it has several potential complications up to 10% of patients. the most frequent complications are bile leakage, tract infection, t-tube dislodgement, electrolyte and nutritional disturbances, cholangitis, or acute renal failure from dehydration due to inadequate water ingestion. it also causes discomfort and persistent pain to the patient along with increased hospital admission and thus the economic burden to the country. primary closure of cbd has been described in the literature to overcome these adverse consequences of the t-tube. however, it has many potential complications as a potential bile leak and cbd stricture, which may occur due to papillary edema and insufficient bile duct expansion. there are conflicting results regarding significant differences in the morbidity and mortality between primary closure and t-tube drainage. there is no conclusive evidence displaying whether primary closure is better or worse than t-tube drainage after cbd exploration. using a biliary stent in primary closure is an effective method to decrease the two complications, which can reduce biliary pressure without bile loss. although there are some available drainage options after cbde, a consensus on the optimal drainage is yet to be reached.

Eligibility criteria:
inclusion criteria * cbd stones * age from 20 to 80, * cbd \> 0.8 cm and \< 2.5 cm, * american society of anesthesiologists (asa) grade i, ii or iii, * agreement to randomization and complete the study requirement. exclusion criteria * acute suppurative cholangitis, * acute biliary pancreatitis, * biliary malignancy, * biliary malformation, * distal cbd stenosis and or obstruction, * trans-cystic stone extraction, * explorations followed by choledochojejunostomy and choledochoduodenostomy.

Keywords: choledocholithiasis t-tube primary repair biliary stenting